MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-02-18 for HEALON PRO TH85ML 10260012 manufactured by Johnson & Johnson Surgical Vision, Inc..
[185112106]
Age/date of birth: unknown, information not provided. Gender/sex: unknown, information not provided. If implanted; give date: n/a (not applicable). The healon pro is not an implantable device. If explanted; give date: n/a (not applicable). The healon pro is not an implantable device; therefore, not explanted. (b)(6). Device evaluation: since no sample was returned and product testing could not be performed; a malfunction is not confirmed. Manufacturing records review: manufacturing record review for product was performed and no deviation related to this complaint was found. All results were within specification and no other complaints have previously been reported on this batch. Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified. All pertinent information available to johnson and johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[185112107]
It was reported that a white foreign substance was noticed upon injecting healon pro into the patient's eye. There was no patient injury reported. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004750704-2020-00011 |
| MDR Report Key | 9723301 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-02-18 |
| Date of Report | 2020-03-29 |
| Date of Event | 2020-01-21 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-02-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SOMYATA NAGPAL |
| Manufacturer Street | 1700 EAST ST. ANDREW PLACE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal | 92705 |
| Manufacturer Phone | 7142478200 |
| Manufacturer G1 | JOHNSON & JOHNSON SURGICAL VISION, INC. |
| Manufacturer Street | RAPSGATAN |
| Manufacturer City | UPPSALA 751 82 |
| Manufacturer Country | SE |
| Manufacturer Postal Code | 751 82 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEALON PRO |
| Generic Name | OVDS |
| Product Code | LZP |
| Date Received | 2020-02-18 |
| Returned To Mfg | 2020-02-11 |
| Model Number | TH85ML |
| Catalog Number | 10260012 |
| Lot Number | UE31579 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON SURGICAL VISION, INC. |
| Manufacturer Address | 1700 E ST ANDREW PLACE SANTA ANA CA 92705 US 92705 |
| Product Code | --- |
| Date Received | 2020-02-18 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-18 |